System and method for transapical access and closure

ABSTRACT

Embodiments are described for creating and closing tissue access ports, such as transapical access ports, which involve placement of an introducer across the subject tissue structure, and deployment of a controllable port closure device assembly configured to remain in place with a ratcheting mechanism, and to hold the tissue surrounding the previous access port location closed against a sealing disc with proximal and distal strut assemblies, after the introducer has been removed.

RELATED APPLICATION DATA

This application is a continuation of U.S. patent application Ser. No.13/725,916 filed on Dec. 21, 2012, which is a continuation of U.S.patent application Ser. No. 13/640,041 filed on Oct. 8, 2012 which is aU.S. National Stage filing under 35 U.S.C. §371 of InternationalApplication No. PCT/US2011/040085, filed Jun. 10, 2011, which claimspriority to U.S. Provisional Application Nos. 61/354,177, filed Jun. 11,2010 and 61/361,365 filed Jul. 2, 2010. Priority to the aforementionedapplications is hereby expressly claimed in accordance with 35 U.S.C.§§119, 120, 365 and 371 and any other applicable statutes.

FIELD OF THE INVENTION

The present invention relates generally to devices and methods forperforming cardiovascular procedures, and more specifically to accessand closure technologies pertinent to transapical cardiac diagnostic andinterventional procedures.

BACKGROUND

Minimally invasive diagnostic and interventional procedure prevalence inUS and foreign hospitals continues to increase, as does the demand forcertain procedures which involve placement of relatively large devicesinto targeted locations within tissue structures of criticality.Procedures such as aortic valve replacement conventionally have beenaddressed with open surgical procedures which are highly invasive. Morerecently, such procedures have been attempted using natural lumen (i.e.,through large blood vessels after an initial surgical transcutaneous orpercutaneous access to such vessels) access and delivery systems.Referring to FIG. 1, such systems typically are configured, for example,to reach the aortic valve (12) location inside of the heart (2) from anantegrade approach, which generally requires navigating instrumentationthrough three of the four chambers of the beating heart (the rightatrium 22, left atrium 8, and left ventricle 20, by way of the mitralvalve 10 and atrial septum), or from a retrograde approach, whichgenerally requires navigating instrumentation along the aortic arch,from the descending aorta (4) to the ascending aorta (6) and adjacentthe aortic valve (12). Each of these approaches presents certainclinical challenges to the surgical team, some of which may be avoidedby using what is referred to as a transapical approach, whereby thesurgeon creates transcutaneous access to the region around the apex ofthe heart (26) with a surgical thoracotomy, followed by direct access tothe left ventricle (20) using a needle or other device aimed to accessthe left ventricle (20) around the left ventricular apex (24), which maybe followed by one or more dilating instruments to create a temporaryaccess port to the left ventricle. Aspects of a conventional accessprocedure are illustrated in FIG. 2, wherein a needle device (34) ispuncturing the muscular heart wall (30) to gain access to the leftventricle (20) around the location of the left ventricular apex (24).Also shown is a guidewire (36) which may be advanced (38) toward andthrough the aortic valve (12) to assist with diagnostic andinterventional aspects of the procedure. Using these and otherinstruments such as dilators, this left ventricular access port may beutilized, for example, to replace an aortic valve if bleeding and tissuedamage around the access port can be successfully mitigated during suchprocedure. Subsequent to such a procedure, the instrumentation needs tobe removed and the access port closed, usually leaving a prothetic valveor portion thereof behind. The successful closure of a transapical woundon a beating heart of a patient is obviously of high criticality to sucha procedure, as is the minimization of loss of blood. Conventionaltransapical closure techniques typically involve the placement of smallsutures to create a purse-string type effect to close the wound as theinstrumentation is withdrawn, and it may be very difficult to repeatablycreate acceptable closures using these techniques without a largerthoracotomy or improved instrumentation. In other words, one of the keychallenges to transapical intervention remains transapical woundclosure. Indeed, it is believed that transapical access may provideenhanced stability and control during procedures such as aortic valvereplacement, due to the fact that the operator may have a relativelydirect mechanical connection with the pertinent instrumentation,relative to the connection that he may have using, for example, anantegrade or retrograde vascular approach with more compliant cathetertype tools. For this reason, it is even more desirable to successfullyaddress the challenges of transapical access and closure.

SUMMARY OF THE INVENTION

One embodiment is directed to an apparatus for closing a defect in atissue wall, comprising a base member having a proximal end and a distalend and a seal member disposed therebetween, the proximal end beingconfigured to be manually manipulated by an operator; wherein the sealmember defines an outer seal margin defining an outer seal diameter; afirst plurality of bendable strut members coupled to the distal end ofthe base member and configured to occupy a collapsed configuration whenbent in place toward the base member, and an expanded configuration whenunrestrained; wherein in the collapsed configuration, each of thebendable strut members project out from a coupling junction with thedistal portion of the base member, sweep toward the proximal end of thebase member, and bend toward the outer seal margin; a proximal hubmember movably coupled to the base member and advanceable along a lengthof the base member; and a second plurality of bendable strut memberscoupled to the proximal hub member and configured to occupy a collapsedconfiguration when bent in place toward the base member, and an expandedconfiguration when unrestrained; wherein in the collapsed configuration,each of the bendable strut members project out from a coupling junctionwith the proximal hub member and sweep toward the distal end of the basemember. The apparatus further may comprise a tubular delivery memberdefining a delivery lumen through which the base member, first pluralityof bendable strut members in a collapsed configuration, proximal hubmember, and second plurality of bendable strut members in a collapsedconfiguration may be advanced by inserting the base member relative tothe tubular delivery member. The tubular delivery member may have anouter diameter configured to be inserted through a defect created in thetissue wall, such that the base member may be further inserted to placethe first plurality of bendable strut members past the tissue wall, outof the delivery lumen, and into the expanded configuration of the firstplurality of bendable strut members. The first plurality of bendablestrut members, upon expansion to the expanded configuration, may occupyan expanded shape having a larger diameter than that of the tubulardelivery member. The base member may comprise an elongate shape withmovement-controlling features configured to controllably resist movementof the proximal hub member relative to the base member. The outer sealmargin may have a substantially circular shape. The first plurality ofbendable strut members may comprise two or more elongate members withproximal ends fixedly coupled to the distal end of the base member in acantilevered anchoring configuration, and distal ends that are free tomove subject to the cantilevered proximal anchoring configuration. Thedistal ends of the bendable strut members may be sharpened. The bendablestrut members comprising the plurality may be substantially equallyradially distributed about a longitudinal axis of the distal end of thebase member. The first plurality of bendable strut members may compriseone pair of bendable strut members. The first plurality of bendablestrut members may comprise three or more bendable strut members. Thefirst plurality of bendable strut members may comprise nitinol alloy.The second plurality of bendable strut members may comprise two or moreelongate members with proximal ends fixedly coupled to the proximal hubmember in a cantilevered anchoring configuration, and distal ends thatare free to move subject to the cantilevered proximal anchoringconfiguration. The distal ends of the bendable strut members may besharpened. The second plurality of bendable strut members may comprisetwo or more elongate members with proximal ends fixedly coupled to theproximal hub member in a cantilevered anchoring configuration, anddistal ends which are joined in an atraumatic loop configuration. Thesecond plurality of bendable strut members may comprise nitinol alloy.The apparatus may further comprise a cannula defining an interior lumenand having an outer diameter, wherein the interior lumen is sized tomovably accommodate the tubular delivery member, and wherein the outerdiameter is sized to be insertable through the defect created in thetissue wall. The apparatus may further comprise a fabric member coupledto the second plurality of bendable strut members and configured tospread loads which may be applied to said strut members by adjacenttissue structures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates aspects of the human heart anatomy.

FIG. 2 illustrates a conventional transapical access procedure.

FIGS. 3A to 3Z-3 illustrate various aspects of various embodiments of asystem for creating transapical access for a diagnostic and/orinterventional procedure, and closing following such procedure.

FIG. 4 illustrates various aspects of a method for creating transapicalaccess for a diagnostic and/or interventional procedure, and closingfollowing such procedure, in accordance with aspects of the apparatusembodiments illustrated in FIGS. 3A to 3Z-3.

FIGS. 5A-5B illustrate an embodiment wherein imaging and measurementtools may be utilized to assist with the accurate orientation andplacement of a transapical access port.

FIG. 6 illustrates various aspects of a method for creating transapicalaccess for a diagnostic and/or interventional procedure, and closingfollowing such procedure, in accordance with aspects of the apparatusembodiments illustrated in FIGS. 5A and 5B.

FIGS. 7A-7B illustrate an embodiment wherein imaging and measurementtools may be utilized to assist with the accurate positioning anddeployment of a transapical access port closure device.

FIG. 8 illustrates various aspects of a method for creating transapicalaccess for a diagnostic and/or interventional procedure, and closingfollowing such procedure, in accordance with aspects of the apparatusembodiments illustrated in FIGS. 7A and 7B.

FIGS. 9A-9G illustrate various aspects of embodiments of a system forcreating transapical access for a diagnostic and/or interventionalprocedure, and closing following such procedure using one or morehelical needles for suture deployment.

FIGS. 10A-10B illustrate various aspects of a suture and anchordeployment embodiment wherein the anchors are placed across thethickness of the subject tissue structure, such as in the leftventricular cavity.

FIGS. 11A-11B illustrate various aspects of a suture and anchordeployment embodiment wherein the anchors are placed within thethickness of the subject tissue structure, such as in the muscular wallsof the left ventricle.

FIG. 12 illustrates one embodiment of a barbed suture and anchorassembly.

FIG. 13A illustrates various aspects of a method for creating andclosing a transapical access, wherein anchors are placed across thethickness of the subject tissue structure, such as in the leftventricular cavity.

FIG. 13B illustrates various aspects of a method for creating andclosing a transapical access, wherein anchors are placed within thethickness of the subject tissue structure, such as in the muscular wallsof the left ventricle.

FIGS. 14A and 14B depict two embodiments of bolstering structuresconfigured to limit protrusion of an introducer member into a tissuestructure such as a left ventricular wall.

FIG. 14C depicts an embodiment having apertures configured for removingfluids near the pericardium in situ.

FIGS. 14D-14E depict an embodiment wherein a steerable catheter withvisualization and vacuum capabilities may be movably coupled to collarmember positioned around an introducer or similar member.

FIGS. 15A-15B depict an introducer embodiment with adiametrically-expandable distal portion.

FIGS. 16A-16E depict aspects of a buckle fastener assembly anddeployment thereof.

FIGS. 17A-17E illustrate aspects of a helical suture member deploymentparadigm.

FIGS. 18A-18C illustrate methods for utilizing helical needleembodiments to close tissue defects with a purse string suturing effect.

FIGS. 19A-19G illustrate aspects of a deployment process utilizing ahelical needle assembly.

FIGS. 20A-20G illustrate aspects of a leak prevention assemblydeployment wherein an inflatable member may be utilized to preventleakage around an intersection of an introducer or similar member and atissue wall.

FIGS. 21A-21J illustrate aspects of a leak prevention assemblydeployment wherein an inflatable member with distal collar member may beutilized to prevent leakage around an intersection of an introducer orsimilar member and a tissue wall.

FIGS. 22A-22 k illustrate aspects of a leak prevention assemblydeployment wherein an inflatable member and tapered distal member may beutilized to prevent leakage around an intersection of an introducer orsimilar member and a tissue wall, and to close the wound that remainsafter withdrawal of the introducer or similar member.

FIGS. 23-25 illustrate various aspects of deployment paradigms similarto those described in reference to FIGS. 20A-22K.

DETAILED DESCRIPTION

Referring to FIGS. 3A through 3Z-3, various aspects of embodiments of atransapical access and closure system are depicted. As shown in FIG. 3A,a transapical access assembly is depicted comprising a needle (34)placed through an elongate dilator member (42), which is slidablypositioned through a working lumen of an introducer sheath (44) whichmay be manipulated using a proximal handle or hub (46). The assembly hasbeen placed through a thoracotomy created in the chest wall (40) of apatient, and directed toward a location on the heart (2) that isdetermined to be close to the apex (24) of the left ventricle (20) usinginformation derived from sources such as anatomic markers, preoperativediagnostic imaging information, such as radiography and/or fluoroscopy,and intraoperative imaging information derived, for example, fromradiography, endoscopy, and/or fluoroscopic imaging of portions of theaccess assembly which may be radioopaque (or radioopaque markers whichmay be fastened to portions of the assembly in one embodiment).Referring to FIG. 3B, after the needle (34) has been inserted across thewall (48) of the left ventricle (20), the dilator (42) followed over theneedle, and the introducer sheath (44) followed over the dilator, theneedle and dilator may be withdrawn, and the introducer (44) left inplace to provide transapical access. The needle preferably comprises aconventional stainless steel needle of approx 18 gauge and may be fittedwith radioopaque markers at known graduated positions and the distaltip. The introducer may comprise an off-the-shelf transapical sheathhaving a working lumen (50) diameter of between about 22 french and 26french, such as those available from Edwards Scientific Corporationunder the tradename “Ascendra”®. Guidewires may also be used in theaccess protocol, as well as elongate access members configured with whatare known as “rapid exchange” features, akin to those described, forexample, by Paul Yock and others in disclosures such as U.S. Pat. No.5,061,273.

FIG. 3C illustrates a close up schematic view of the introducer (44) andleft ventricular wall (48) paradigm, with reference to the chest wallboundary (40). With an introducer (44) in place, as depicted in FIGS. 3Band 3C, a diagnostic and/or interventional procedure may be conducted,such as an aortic valve replacement using a prosthesis such as thatmarketed by Edwards Scientific Corporation under the tradename“Sapien”®. Subsequent to the diagnostic and/or interventional procedure,a closure procedure may be conducted, in accordance with theconfigurations depicted in FIGS. 3D through 3Z-3. Referring to FIG. 3D,a closure device assembly may be inserted through the introducer. Theassembly embodiment depicted in FIG. 3D comprises a plurality of distalstruts (54) coupled to a disc or seal member (56), which is coupled toan insertion assembly comprising a thin elongate proximal portion (64)that leads out proximally to a position wherein it may be manipulated byan operator, and a thicker distal portion (66) that is fixedly coupledto the disc member (56). A proximal hub member (60) is slidably coupledabout the insertion assembly, and is coupled to a plurality of proximalstruts (58). The hub member (60) is removably coupled to a pusher member(68) which leads to a proximal position wherein it may be manipulated byan operator to advance or retract the hub relative to other portions ofassociated assemblies, such as the insertion assembly (64, 66). Suchclosure device assembly may be slidably positioned within a workinglumen of a delivery sheath (52) when presented to the introducer sheath(44), and the delivery sheath (52) and closure device assemblypreferably may be inserted together relative to the introducer sheath(44).

Referring to FIG. 3E, a close up side view of a closure device assemblyis depicted, showing the distal struts (54), disc member (56), proximalintroducer assembly portion (66), proximal hub (60), and proximal struts(58) in greater detail. In one embodiment, the proximal (58) and distal(54) struts comprise nitinol wire thermally set into the depictedarcuate shapes, the wire having an outer diameter in one embodiment ofabout 0.023 inches. While the depicted embodiments comprise five distal(54) and five proximal (58) struts, other combinations may be utilized,such as 1 proximal/1 distal, 2 proximal/2 distal, 3 proximal/3 distal, 4proximal/4 distal, 6 proximal/6 distal, and so on; further, it is notrequired that the number of struts proximally match the numberdistally—thus a 6 proximal/3 distal configuration may be utilized, forexample. Preferably the proximal and distal struts are rotatablyoriented relative to each other to interdigitate as they are closed, asdescribed below in reference to FIG. 3G, and to provide for anchoring ofthe sides of the tissue structure around the defect toward each other.Indeed, in some instances, due to the natural dynamics of the tissuecomprising the LV apex, a successful closure result may be tied moreclosely to anchoring the portions of tissue around the defect together(i.e., providing/encouraging tissue apposition) to allow for bloodclotting than to total hemostatic sealing.

In one embodiment, the ends of the proximal (58) and distal (54) strutsare sharpened to encourage insertion of such ends into tissue that theymay be urged toward. The proximal hub (60) and disc member (56) maycomprise relatively bioinert materials or composites which have at leastsome portions having greater stiffness than the materials comprising thestruts, to facilitate support of associated structures such as theproximal strut portions. For example, in one embodiment, the proximalhub (60) and disc member (56) comprise titanium metal encapsulated in arelatively inert polymer such as nylon or Delrin®. In anotherembodiment, the disc member (56) may comprise a compliant solidmaterial, and/or a non-solid construct, such as a structure made fromtextile-like materials, such as Dacron®, which may be reinforced by anassociated external cage or hoop member. An integrated prothrombogenicpad (70), such as one made of gelfoam material, may be coupled to theproximal hub (60) to prevent bleeding around the area of interfacebetween the proximal struts (58) and tissue of the heart wall which maybe captured between the proximal (58) and distal (54) struts or adjacentthereto. The outer diameter of the disc member (56) preferably ismaximized relative to the delivery sheath (52) and introducer sheath(44) configuration, as the disc member (56) is designed to work as aseal or plug of sorts for the wound left by the transapical access port,in concert with the proximal (58) and distal (54) struts, which areconfigured to urge nearby tissue against the disc member (56) to closethe access port, as described in further detail below. In anotherembodiment, the disc member may be configured to expand in situ toprovide additional wound plugging/sealing geometric advantages inassociation with captured tissue and sets of struts. Each of the distalstruts (54) in the depicted embodiment is bent to contain a capturedangle of about 35 degrees when in free space, with a relatively smoothand atraumatic bend distally. The proximal struts (58) project from theproximal hub (60) at a similar angle, but without the reversing bend asin the distal struts (54) in the depicted configuration. Referring tothe orthogonal view of FIG. 3F, it may be seen more clearly that thedepicted embodiment has five struts proximally and distally. Further,the proximal portion (66) of the insertion assembly has one or more flatsurfaces that interface with flats within the proximal hub (60) tomaintain a rotational orientation of the proximal hub relative to thedistal struts (54) which is selected to allow the proximal struts (58)to interdigitate with the distal struts (54) as the proximal hub (60) isadvanced toward the disc member (56), such interdigitation beingdesirable for grasping tissue without shearing or slicing it. Thisrelative rotational orientation is illustrated in the front view of FIG.3G. Referring to FIG. 3H, another orthogonal view of the same assemblyis depicted to show that two ratchet members (72) are movably coupled tothe proximal hub (60) and designed to interface with two sawtooth typeratchet tracks formed into the proximal portion (66) of the insertionassembly. When the proximal hub (60) is being advanced over theseratchet tracks, the ratchet members (72) are configured to allow furtherinsertion, but to prevent retraction (i.e., proximally toward thethoracotomy) of the hub (60). In other words, once the proximal hub (60)has been inserted onto the ratchet tracks of the proximal portion (66)of the insertion assembly, it is locked into a one-way movementparadigm; until it is inserted onto such ratchet tracks, the hub may beretracted and inserted using the proximal hub pusher member (element 68in FIG. 3D). Referring to FIG. 3I, a closure device assembly is depictedhaving a different set of proximal struts. The atraumatic proximalstruts (59) are configured to not insert into adjacent tissues duringdeployment, but rather to spread loads relatively atraumatically uponsuch adjacent tissues with loops that are heat formed into the strutsusing similar materials and forming techniques as used for the distalstruts (54). FIG. 3J shows a front view to illustrate the relativerotational orientation of the proximal and distal struts (59, 54) thatis enforced with flats or other similar rotational orientation enforcingfeatures at the interface between the proximal hub (60) and proximalportion (66) of the insertion assembly. Referring to FIGS. 3J-i and3J-ii, a frustoconical fabric member (232), comprising one or morelayers of a material such as Dacron® fabric, may be coupled to thedistal aspect of the proximal struts (59—or 58 in other embodiments) tode-concentrate, or spread, loads that may be applied to nearby cardiactissues through such struts, due to the fact that such material hashigher structural material compliance than the materials preferred forthe struts, and is presented to the tissue with a larger surface area,as in the depicted embodiment. The fabric may also help to controland/or mitigate minor bleeding which may be present at the nearby tissuestructure surface.

Referring to FIG. 3K, picking up again from where FIG. 3D left off inthe depicted deployment process, the closure device assembly andassociated delivery sheath (52) has been further inserted into thepatient. Referring to FIG. 3L, when the operator desires to begininstallation of the closure assembly, the insertion assembly (64, 66)may be advanced relative to the delivery sheath (52) and introducer (44)to a point wherein the distal struts (54) are able to bend past thedistal ends of the delivery sheath and introducer sheath (78, 76) andassume their heat shaped configurations (i.e., without the deliverysheath or introducer sheaths inner lumen walls constraining them into amore compressed configuration, as they may be during insertion).Generally the distal struts (54) are configured to expand past the outerdiameter of the introducer sheath (44) to be able to capture and anchorto the nearby tissue. In one embodiment, the distal struts areconfigured to expand by about 20% in diameter (i.e., from a containeddiameter of about 26 french to an uncontained diameter of about 31french) when allowed out of the constraints of the delivery andintroducer sheaths, and this expansion assists with capturing portionsof a ring of tissue about the surgically-created transapical defect thatmay be pulled in toward the disc member (56) to create a wound pluggingor closing effect. This radial expansion (74) of the distal struts isillustrated in FIG. 3L. Referring to FIG. 3M, with the distal struts(54) expanded to their heat-formed configurations, to assist inproviding enough tissue purchase by the distal struts (54), theintroducer sheath (44) and delivery sheath (52) may be withdrawn,thereby allowing nearby tissue to migrate inward (80) toward the discmember (56). This withdrawal may be simultaneous or sequential (FIGS. 3Mand 3N depict a partial sequential withdrawal—first of the introducersheath 44, then of the delivery sheath 52; FIG. 3O depicts asimultaneous withdrawal of both sheaths 44 and 52 together, to allowfurther inward migration 80 of the viscoelastic tissue that forms theleft ventricular wall 48). The proximally pointed distal tips of thedistal struts (54), along with the arcuate, curved nature of the distalstruts (54) and proximal advancement of them into the tissue as in FIGS.3N-3P with purchase of the tissue as the introducer retraction is begunprovides an important anchoring and grasping of the tissue toward othertissue, which also closes the wound around the proximal aspects of thedevice. In other words, the deployment bunches nearby tissue towarditself, providing for a heart cavity exposure that consists mostly oflive tissue anchored about a plurality of relatively small distal struts(54). This minimal hardware exposure is preferred for biological tissuecoverage (i.e., endotheliziation) advantages, and avoids discontinuitiesand/or necrosis in the critical endocardial tissue surface that mayresult from prostheses with larger endocardial device exposure.Referring to FIG. 3P, the insertion assembly (64, 66) may then be pulledtoward the operator to assist with seating the distal struts (54) intothe captured tissue if they have not already seated themselves (i.e.,given the sharpened tips and spring like nitinol material of the abovedescribed variations), at which point a sealing of the transapicalaccess wound may be formed given the interaction of the distal struts(54) and disc member (60), which effectively capture and bunch inwardlya portion of tissue surrounding the left ventricular cavity side of thetransapical access wound. Referring to FIG. 3Q, the introducer sheath(44) and delivery sheath (52) may be further withdrawn to allow furthermigration (80) of the viscoelastic tissue comprising the transapicalaccess wound. Referring to FIG. 3R, the proximal hub (60) and associatedproximal struts (58, or in the case of an embodiment such as thatdepicted in FIGS. 31 and 3J, element 59) may be advanced toward the discmember (56) using the proximal hub pusher member (68); in the embodimentdepicted in FIG. 3Q, the introducer sheath has been completely removed;in other embodiments, it may remain and be moved in parallel with thedelivery sheath (52). Referring to FIG. 3S, the proximal hub (60) may befurther advanced (88) and/or or the delivery sheath retracted (90) toallow the proximal struts (58) to become free and bend past the distalend of the delivery sheath, and be inserted toward the disc member (56)to capture proximal portions of tissue comprising the transapical accesswound and urge them toward the disc member (56), as shown in FIG. 3T. Atsuch level of proximal hub (60) insertion, the proximal hub (60) hasentered the ratchet tracks formed into the proximal portion (66) of theinsertion assembly, and one way locking action of the hub (60) isenforced to facilitate secure positioning and maintenance of the closureassembly. At this point the transapical access wound is effectivelyclosed, with proximal (58) and distal (54) struts urging tissue portionstoward the disc member (60) to create a sealed wound that will becomefurther biologically integrated over time.

Referring to FIG. 3U, the proximal hub pusher member (68) may bedecoupled from the proximal hub (using, for example, a threadedinterface that may be controllably detached using rotation of the pushermember 68) and withdrawn (92) proximally. Referring to FIG. 3V, anoptional prothrombogenic pad (96), such as one made of gelfoam material,may be installed over the deployed closure device proximal aspects usinga pad inserter member (94) defining a lumen (100) through which portionsof the insertion assembly (64, 66) may be passed. The pad insertermember (94) may have a frustoconical distal portion (98) configured tobroadly interface the prothrombogenic pad against the targeted closuredevice and tissue structures, as shown in FIG. 3X, after furtheradvancement (102) of the pad inserter member (94) and/or retraction (90)of the deployment sheath (52). With the prothrombogenic pad (96) inplace, the pad inserter member (94) may be retracted (104) as shown inFIG. 3Y, and a cutter assembly, comprising, for example, a cutter (106)and two cutter actuation members (108, 110), may be advanced toward thedeployed closure device, as shown in FIGS. 3Z and 3Z-1. In the depictedembodiment, the two cutter actuation members (108, 110) are configuredto cause the cutter (106) to shear off any elongate members passedthrough it, such as any portions of the insertion assembly proximalportion (64) or distal portion (66) which may be passed therethrough.Referring to FIG. 3Z-2, the insertion assembly proximal portion (64) hasbeen intentionally cut close to the deployed prothrombogenic pad (96),leaving behind a minimal amount of hardware protruding proximally fromthe closed transapical access wound when the remaining uncoupledinstallation hardware is withdrawn (114). The resultant deployed closureassembly (116) is depicted in FIG. 3Z-3.

Referring to FIG. 4, a method of deploying a wound closure device, usingtechniques such as those described in reference to FIGS. 3A through 3Z-3is illustrated. After transcutaneous chest access is created (forexample, by a thoracotomy) (168), access may be surgically created toreach the left ventricle (170) and an introducer sheath installed (172).The introducer sheath may be utilized to conduct a diagnostic and/orinterventional procedure, such as a aortic valve replacement (174),subsequent to which the related diagnostic and/or interventional toolsmay be withdrawn (176) and closure begun. In the depicted embodiment, atransapical wound closure device assembly (comprising structures such aselements 54, 56, 66, 58, 60, 64, 68 of FIG. 3D, for example) positionedwithin a delivery sheath (52) may be introduced through the introducersheath (178) and advanced to allow distal struts to expand past thedistal portions of the introducer sheath and delivery sheath (180). Theintroducer and delivery sheathes may be withdrawn (184) in parallel, orin advance, or withdrawal of the device assembly (182) to capture sometissue between the distal struts (54) and the disc member (56). Theproximal hub (60) may be advanced (186) to engage tissue between theproximal struts (58) and the disc member (56) with ratcheted mechanicalstability provided by the interfacing features of the proximal hub (60)and distal portion (66) of the insertion assembly. With the proximal hub(60) in position causing the proximal struts to urge the proximal aspectof the wound toward the disc member (56) and cause additional sealing ofthe wound, the proximal hub advancing member (i.e., the pusher member68) may be removed (188) and a prothrombogenic pad (96) may be advancedthrough the introducer sheath and/or delivery sheath using a padinserter member (94), and against the tissue and device structures thatare proximally available to the pad (190). The pad inserter member (94)may be removed (192), and a cutter assembly advanced through theintroducer and/or deployment sheath (194). The cutter may be utilized tocut away (196) proximal portions of the insertion assembly, and theuncoupled portions may be withdrawn proximally (198), after which thetranscutaneous access port may be closed (200).

Referring to FIG. 5A, a configuration similar to that described inreference to FIG. 3A is depicted, with the exception that the introducersheath (44) in the embodiment of FIG. 5A is instrumented with additionaltechnologies, such as an image capture device (118) and opticalcoherence tomography (“OCT”) device (120) to facilitate introducerplacement across a critical tissue structure, such as the leftventricular wall (48). As shown in the cross sectional view of FIG. 5B,the image capture device preferably comprises an optical fiber bundle ora digital imaging chip, such as a CMOS, CCD, or other high resolutionimage capture device similar to those utilized in socalled “chip on thetip” laproscopy, which is coupled to an image processing and/or capturesystem (element 126 referring back to FIG. 5A) by an electric lead inthe lead bundle that couples the device (118) and the system (126). Thesystem may also comprise an illumination source which may pass lightradiation to the operational theater in situ using a fiber bundle (122)which may also comprise part of the lead bundle leading back to thesystem (126). An irrigation port (124) may also be present to allow forcontrollable irrigation, vacuum, and/or medicine, contrast agent, orother solution delivery to the operational theater in situ. As shown inFIG. 5B, the OCT device (120) may comprise a fiber or fiber bundle onthe introducer side that leads proximally back to an interferometrysystem (128) capable of generating images as well as distanceinformation, such as the thickness of the left ventricular wall (48)straight ahead in situ, for the operator. A combination ofintraoperative direct visualization using image capture, irrigation, andor illumination, as well as intraoperative three dimensional image andmeasurement feedback from a system such as OCT, is selected to providean operator with valuable and fresh information as he selects aninsertion vector position for the pertinent instrumentation. Referringto FIG. 6, a method is depicted wherein after creating transcutaneousaccess (168), as in FIG. 4, a left ventricular access deviceconfiguration may be navigated, positioned, and oriented using freshinformation from forward oriented direct visualization and imagingand/or measurement features of onboard OCT technology (202). These sameimaging and information technologies may be utilized during insertion ofthe device components to confirm positioning and continue to providefresh information for the operator (204). Subsequently, the diagnosticand/or interventional steps (174), as well as other steps (206), may beconducted as described above.

Referring to FIG. 7A, an embodiment similar to that described inreference to FIG. 3T is depicted, with the exception that an elongateimaging platform (130) has been inserted through the deployment sheath(52) and over the insertion assembly (64, 66) and pusher member (68)using a lumen defined through the elongate imaging platform (130). Animage capture device (118) and irrigation port (124) are locateddistally and coupled through the elongate imaging platform (130) to animage capture and illumination system (126) and an irrigation system(127). Referring to FIG. 7B, a cross sectional view is depicted to showthe various distal components. In the depicted embodiment, the elongateimaging platform may be rotated relative to the closure devicecomponents and left ventricular tissue—to enable the various irrigation,image capture, illumination, and other components access more of thepertinent forward oriented activity. On board OCT (not shown) may alsobe included in the form of an additional fiber or fiber bundle throughthe elongate imaging platform that is proximally interfaced with an OCTinterferometry system configured to provide images and measurements.Referring to FIG. 8, aspects of a method are depicted wherein subsequentto other procedural steps (208), such as those described above inreference to FIG. 4, for example, a transapical closure device may beinserted (178), and the interaction (210) between left ventriculartissue and closure device assembly portions observed and characterizedwith imaging, measurement, and irrigation features that are movablerelative to the tissue and closure device. In one embodiment, forexample, an image capture device and irrigation port may be utilized tocheck for leaks around each portion of the circumference of the proximalaspect of the device-closed wound. Further, sealants, medicines, andother solutions may be applied with direct visualization. Subsequently,other steps of diagnostic and/or interventional procedures, such asthose described above, may be conducted (212).

FIGS. 9A-12 depict aspects of other embodiments for closing woundscreated across tissue structures such as the wall of the left ventricle,using helically advanced sutures. Referring to FIG. 9A, in introducersheath (44) has been advanced into the left ventricle using techniquessuch as those described above. Subsequent to conducting pertinentdiagnostic and/or interventional procedures using the introducer, ahelical suture closure device may be utilized to assist with closure ofthe transapical access wound. As shown in FIG. 9A, a helical suturingassembly embodiment comprises a needle insertion member (144) fixedlycoupled to two helical needles (132, 134). In the depicted embodiment, afirst helical needle (132) has a helical radius that is larger than thehelical radius of the second helical needle (134). Each of the helicalneedles preferably comprises a relatively stiff and hollow construct,made from a material such as stainless steel. Threaded through the firsthelical needle (132) is a first suture (140) which is coupled distallyto a first distal anchor member (136). Similarly, threaded through thesecond helical needle (134) is a second suture (142) which is coupleddistally to a second distal anchor member (138). The ends of the needles(132, 134) preferably are sharpened to facilitate access into pertinenttissue structures. FIGS. 9B and 9C depict additional orthogonal views ofthe helical needles and a distal portion of the needle insertion member(144). FIG. 9D depicts a close up orthogonal view of the previouslydepicted first and second helical needles (132, 134) and distal anchormembers (136, 138). The anchor members preferably are geometricallyconfigured to slidably and removably engage the distal ends of thepertinent helical needles, and to fasten or hook onto tissue andslidably disengage from the needle distal ends when the helical needlesare rotated counterclockwise in the depicted example embodiment. Inother words, with such embodiment, as the helical needles are advancedthe needle insertion member (144) is rotated clockwise, the anchors areconfigured to stay in place at the distal ends of the needles; once theneedle insertion member rotation is reversed to counterclockwise, smallfeatures on the anchor members (136, 138) are configured to catch uponthe nearby tissue, pull the anchors out of their positions transientlyhoused in the needle tips, and begin to pull suture through the hollowneedles, leaving helical suture paths with distal anchors, as shown, forexample, in FIGS. 10A-10B, and 11A-11B. Referring to FIGS. 9E-9G,various anchor configurations (136, 146, 148) are shown, each of whichhas one or more features (150) configured for fastening a suture orother tensile member, and each of which has geometric featuresconfigured to catch upon nearby tissue structures when moved backwardrelative to such tissue structures. Referring to FIGS. 10A-10B, anembodiment is depicted wherein the anchors have been helically drivenacross the thickness of the left ventricular wall (48) such that theyare located within the left ventricular chamber. Referring to FIG. 10B,they may be tensioned concomitant to withdrawal of the introducer toclose the transapical access wound. In one embodiment, the two sutures(140, 142) may be tensioned simultaneously. In another embodiment, theymay be tensioned sequentially. In yet another embodiment, combinationsof parallel and sequential tightening may be utilized. For example, inone embodiment, initially both may be tightened in parallel to a firsttension level using manual manipulation from the operator (i.e., usinggraspers or other instruments placed through the chest wall, or bypulling the suture ends up across the thoracotomy where they may bemanipulated outside of the body), after which a second higher tensionlevel may be achieve in the first suture with the larger helicaldiameter, followed by final “fine tuning” tension to take the secondsuture with the smaller helical diameter to a higher tension level thatmay be equivalent to the second tension level of the first suture. Suchan approach is believed to assist with complete closure of woundswherein the inner (i.e., near the smaller helical diameter suture)portions of the tissue may have been plastically deformed to a greaterdegree than the outer portions (i.e., near the larger helical diametersuture) due to the process of blunt surgical access tool insertion.FIGS. 11A-11B depict a tightening scenario similar to that of FIGS.10A-10B, with the exception that the helical needles (132, 134) andanchor members (136, 138) are only advanced to the midportion of thethickness of the tissue structure wall (i.e., not all the way across, asin the embodiment of FIGS. 10A-10B).

In one embodiment the sutures may be comprise barbed suture material,such as those available from Angiotech Corporation under the tradename“Quill”®. Referring to FIG. 12, in another embodiment, relativelyhigh-load barbed suture (154) may be formed using a braided suture bodymaterial (154), such as a Dacron® braid, into which small barbs (156)have been placed, which enough length inserted into the suture bodymaterial to prevent the barbs (156) from becoming substantiallyrepositioned, and enough load bearing capability in each of the barbs toprovide a net tensile load resistance that is relatively significantwhen applied to an anchored suture placed at least in part between thetwo margins (158, 160) of a tissue structure.

The suture proximal ends (152) depicted in FIGS. 10B and 11B may be tiedto each other to maintain tension on the sutures, or may be placed intopermanent or semipermanent levels of tension utilizing small buckles orsuture tensioners, in addition to conventional pledgets and surgicalknots which may be used for each suture, or the two or more sutures astied together.

Referring to FIG. 13A, a method for creating, utilizing, and closing atransapical access wound using a helical needle configuration such asthose described in reference to FIGS. 9A-9G and 10A-10B is depicted,with some steps similar to those described in reference to FIG. 4, forexample. Subsequent to creation of access to the thorax (168), access tothe left ventricle (170), installation of an introducer sheath (172),and use of such configuration to conduct a diagnostic and/orinterventional procedure (174), the diagnostic and/or interventionaltools may be retracted (176) before, after, or during advancement of ahelical closure device over the introducer (214). One or more helicalneedles may be advanced across the left ventricular wall (216), and withbackwards helical retraction (218) of the helical needles, one or moreanchors may be left behind, the anchors being coupled to sutures whichpreferably are proximally threaded through the helical needles to aposition wherein they subsequently may be controllably tensioned by thesurgeon (220) to create a transient hoop stress around the introducersheath to facilitate sealing around the introducer as the introducer iswithdrawn (222, 224) with interactive adjustment of the suturetensioning to prevent leakage. The tensioning may be fine tuned (226),as described above, and the suture tensioning may be locked into place(288). Finally, extra uncoupled proximal suture material and any otherdeployment hardware may be removed, and the transcutaneous access portclosed (230). Referring to FIG. 13B, an embodiment similar to that ofFIG. 13A is depicted, with the exception that the helical needles areonly advanced into the midsubstance of the left ventricular wall (232),not fully across such wall.

Referring to FIG. 14A, in one embodiment, a bolster flange (161)structure or feature may be included near the distal end of theintroducer sheath (44) to only allow the introducer sheath (44) toprotrude into the left ventricular wall (48) by a predetermined amount(162). In another embodiment, a bolster sleeve (163) may be movablycoupled to the introducer sheath (44) to have a similar function, and inone embodiment, such bolster sleeve may be adjustable in positionrelative to the introducer sheath (44) to allow for adjustment of thepredetermined sheath distal protrusion distance (162), using adjustablemechanical couplers such as the screw type couplers (164, 166) depictedin the embodiment of FIG. 14B.

Also shown in FIG. 14A is a series of apertures (236) which are in fluidcommunication, via a vacuum lumen (234) and vacuum line (238), with avacuum source or vacuum pump (240). The apertures (236) and vacuum (234)may be utilized to remove blood and other fluids which may ooze or leakfrom the surrounding tissues during the procedure. This may be importantin transapical procedures to remove blood or other fluids which may, forexample, enter the pericardium and potentially lead to pericardialtamponade or other undesirable conditions. The embodiment of FIG. 14Afeatures the apertures (236) distributed around the bolster flangestructure (161). Referring to FIG. 14B, a similar configuration hasapertures distributed around the distal portion of the bolster sleeve(163). Referring to FIG. 14C, another embodiment shows apertures (236)distributed around an introducer sheath (242) that does not have abolstering structure (i.e., a bolstering structure need not be presentfor the vacuuming apertures to be featured in a given embodiment), andhas two circumferential sets of apertures (236) to provide furthervacuuming access; many distal aperture configurations may be suitable.

Referring to FIG. 14D, another embodiment is shown wherein an elongatesteerable instrument body (350), such as one associated with a manuallyor electromechanically steerable catheter system, may be passed througha lumen (358) formed in a movable collar member (356) coupled around theintroducer (44). Preferably the movable collar member (356) may berotated and inserted/withdrawn relative to the introducer (44).Preferably the steerable instrument body (350) may be inserted/withdrawnand rotated relative to the movable collar member (356). Preferably thedistal end of the elongate steerable instrument (350) carries an imagecapture interface (354), such as a digital imaging chip or fiber imagingbundle termination, as well as an illumination source (such as a lightfiber termination—preferably positioned immediately adjacent the imagecapture interface 354) and vacuum inlet (364, such as the end of a tubeleading proximally to the vacuum source 240). The depicted embodimenthas a manual handle and steering interface (348) disposed proximally,and leads (238, 125) connecting a vacuum source (240) andillumination/image capture system (126) to the elongate body (350) anddistally disposed illumination outlet, image capture interface (354),and vacuum inlet (364). Pullwires (not shown) may operatively couplemanipulation elements of the proximal control interface (348) toportions of the elongate body to provide for controlled steerability,preferably to provide at least controllable pitch and yaw steerability.A display may be operatively coupled to the image capture andillumination system (126) to facilitate operator observation of activitywithin the field of view of the distally disposed image captureinterface. The degrees of freedom of the steerable instrument (350) andmovable collar member (356) working together provide an operator withthe ability to move the distal portion of the steerable instrument allaround the immediate area where the introducer (44) has been passedthrough the left ventricular wall (48). The distal portion of themovable collar member (356) may also feature an image capture interface(352) configured to have a distally-oriented field of view to generallycapture activity of the distal portion of the steerable instrument(350); this second image capture interface (352) may also be operativelycoupled to the image capture and illumination system (126) and display(346), and a second illumination outlet may be featured adjacent thesecond image capture interface (352). Referring to FIG. 14E, a close-upview of certain aspects of the illustration of FIG. 14D is depicted. Inpractice, the depicted embodiment may be utilized to examine the areaaround the introducer (44) and heart wall (48) junction, and vacuum anyextra fluids which may be present. For example, in one embodiment, themovable collar member may first be inserted through the transcutaneouschest port and into a position as shown in FIG. 14D. The image captureinterface (352, a digital imaging chip, in one embodiment) androll+insertion/withdrawal degrees of freedom of the collar member (356)may be utilized to generally investigate the area around theintroducer/heart wall junction, with the field of view of the collarmember image capture interface (352) having a distally-oriented field ofview (360) configured to capture not only the introducer/heart walljunction area, but also the distal portions of instruments passedthrough the working lumen (358) formed within the collar member (356)—asin the depicted embodiment, wherein the distal portion of the steerableinstrument (350) is positioned through such lumen (358) and free tocontrollably articulate or bend around in the area to investigate nearbystructures and vacuum away fluids. The distal portion of the steerableinstrument (350) in the depicted embodiment carries its own imagecapture interface (354), which also has a distally-oriented field ofview (362) configured to capture images of nearby tissues, as well as atleast a portion of the distal vacuum interface (364)—to enable theoperator to navigate the instrument around, capture images of structuresaround the instrument, and also capture images of the distal vacuuminterface (364). Such an arrangement allows the operator to use thedisplay to see the view from the second image capture interface (352),as well as a view from the first image capture interface (354), to movethe various structures appropriately, see what he wants to vacuum, andoperate the vacuum with real time, or near real time, visualconfirmation of what he is vacuuming. In one embodiment, thisarrangement may be utilized to vacuum away blood and other fluids whichmay be present in the region, to prevent cardiac tamponade or otherundesirable fluid-related scenarios.

Referring to FIGS. 15A and 15B, another embodiment of an introducer(244) is depicted having a diametrically expandable (i.e., the outerdiameter of its distal portion is controllably expandable) distalportion, which is configured to assist in preventing the introducer frombeing pulled or removed proximally of the tissue wall (48) until a timethat is desired. As shown in FIG. 15A, the introducer (244) may beinserted as described above, but to an increased depth to allow for adistal portion (246) to protrude into the cavity opposite the tissuestructure wall (48). At a desired time, the distal portion (246) may becontrollably expanded to have a larger outer diameter (254) by rotatinga structural member (252) from a proximal location, causing thestructural member to be loaded in tension due to its coupling distally(250) with the introducer (244). When desired, the structural member(252) may be counter-rotated to cause the distal portion to again resumethe configuration shown in FIG. 15A, to facilitate removal of theintroducer (244).

As described above in reference to FIGS. 10B and 11B, for example, smallfasteners may be utilized to maintain tension on deployed sutures.Referring to FIGS. 16A-16E, one embodiment of a buckle type fastenerassembly (256) is depicted wherein a winding block (258) is configuredto be deposited into a block cavity (274) of a buckle body member (260).The winding block (258) comprises an aperture (264) through which suturematerial may be passed and/or fastened, and is configured to have suturematerial wound around it and passed down through a distal outlet toaccess nearby tissue structures. FIG. 16B shows that the distal outlet(262) may be positioned at an angle (268) relative to a vertical line(266), the angle selected to accommodate a helical pitch of a deployedhelical suture—so that tension applied through the associated suture isapplied at least somewhat parallel to the path of the suture, and ismore likely to retain the helical pattern of the suture deployment (andless likely to cause shearing or cutting loads in nearby tissue as wouldsuture loads that are more perpendicular to the helical pattern; suchperpendicular loads are more likely to be present without someredirecting of the suture tensile loading). In other words, theangulation (268) of the suture pathway through the buckle body serves asa force re-director. FIG. 16C depicts a top orthogonal view showing thesuture pathway (272) through the lower buckle body (260). Referring toFIG. 16D, in application and before complete deployment, a suture (140)leads from a proximal location, helically around the winding block (258)and through the aperture (264) thereof, into the block cavity (274),through the distal outlet (262), and into contact with the subjecttissue structure. Referring to FIG. 16E, one deployment scenario isdepicted to further illustrate use of the depicted configuration. Asshown in FIG. 16E, a suture (140) has been helically deployed with ananchor (136) at its distal end on the opposite surface of a tissuestructure, such as a left ventricular wall (48). The buckle body (260)may be slid over the suture distal outlet first (262), along with thewinding block (258) with winding loops of suture around it. With acompressive load (276) to press the buckle body (260) against the tissuestructure (48), a containment member (293) to retain the winding block(258) within the block cavity (274), and a tensile load (291) upon theproximal end of the suture (140), the suture may be locked into tension.The looping pattern of suture around the winding block (258), along withthe physical confinement of the winding block in the block cavity (274)and the related engagement loads, result in a one-way tighteningmechanism such that the slack may be pulled out with proximal tension,but movement of the suture in the other direction is prevented by thebuckle assembly.

Referring to FIGS. 17A-17E, a helical suture deployment embodiment isdepicted wherein the suture material may be carried upon an outer rail(285) of a helical needle (284) and deployed away from the needle withcounter-rotation action of the helical needle, such as by manualrotation of a proximal handle (278) from outside of the patient's body.The handle (278) may be coupled to the helical needle (284) with anelongate instrument shaft (280) and helical needle coupler (282), whichmay also be coupled to a portion of an instrument such as an introducersheath (44). The suture rails (285) are shown in further detail in theclose up view of FIG. 17B. Referring to FIG. 17C, in use, the helicalneedle (284) may be rotated (286) into a tissue structure such as a leftventricular wall (48) to deposit a suture with distal anchor (notshown). One of the challenges in deploying a suture from such a railconfiguration is tightening the helical suture once it has beenhelically positioned, since friction becomes a significant factor, andnonlinearities of the viscoelastic tissue can magnify this. When asuture or other tensile member is helically wrapped around a shaft, asshown in FIG. 17D, for example, we have determined that the maximumratio of loads that may be applied (F2 to F1—elements 296 and 294,respectively) may be calculated with the depicted formula (298), whereintheta (292) is the helical wrap angle on the shaft, and mu (290) is thestatic friction coefficient between the tensile member material and theshaft (288). Referring to FIG. 17E, these relationships may be appliedto a helical suture (140) deployed in situ through a left ventricularwall (48) between two surfaces (300, 302) of the heart, wherein a“shaft” or “column” of tissue (304) is effectively captured by thehelical winding pattern which may be formed by a helical needle withrail-deployment. An anchor on the opposite side of the distal surface(300) creates F2 (296), while a proximal pull creates F1 (294). We havefound in experiments that in certain configurations, with a proximalpull (294), we are only able to tighten the distal few windings (306) ofthe helically deployed suture, while the proximal windings (308) maystay relatively slack. This is a result of the equation (298) of FIG.17D at work—the friction formed by the large surface of windings is toogreat to be entirely tensioned by the applied loads. As a result, wehave created techniques to sequentially tighten portions of the helicalsuture, as described further in reference to FIGS. 18B and 18C.

Referring to FIG. 18A, in a simple configuration, a helical suture isdesired for a defect closure (310), a helical needle with railconfiguration is driven to place an anchor at a desired distal location(312), and the needle may be helically retracted to decouple the suturefrom the needle suture rail (314) after which it may be tensionedproximally to create a purse-string closure of the wound, and fastenedto retain tension (316). The helical winding angle, friction surfaces,and number of windings may be selected to allow for complete tensioningwith proximal loading.

Referring to FIG. 18B, in another embodiment, after a similar two steps(310, 312), the helical needle may only be partially retracted (318),followed by a proximal tensioning to place this first portion ofhelically deployed suture into tension (320). Then a pledget or othertension-retaining member may be advanced into place, and the process oftensioning the next proximally adjacent helical suture sequence (322)may be conducted—and repeated (324) as necessary to effectively form aserial chain of tensioned helical sutures which may ultimately beproximally fastened to retain tension (326). Such a configuration may beutilized to provide a very robust helical tightening and wound closure.Referring to FIG. 18C, a similar sequential tightening may be utilizedaround an elongate instrument, such as an introducer, to prevent leakageduring use, and to close sequentially after use. As shown in FIG. 18C,an elongate instrument may be installed, creating a defect in a tissuestructure (328). A helical needle and suture assembly may be advancedover the elongate instrument (330) and tensioned to prevent leakagearound the instrument during use (332). After conducting a diagnosticand/or interventional procedure with the elongate instrument (334), theinstrument may be sequentially withdrawn as the helical suture is alsosequentially tightened—both around the portions of the instrument stillin place, and also to bring the tissue into apposition/closure in theplaces where the instrument has been withdrawn away (336). The sequencemay be repeated until the defect is closed and the suture fastened inplace to retain tension.

Referring to FIGS. 19A-19G, a helical suture deployment is depictedaround a wound formed by insertion of an introducer (44) and dilator(342) instrument set. Referring to FIG. 19A, a dilator (342) is showninserted through the working lumen of an introducer catheter (44), bothof which are inserted through a tissue structure wall such as a leftventricular wall (48). As described above, a helical needle coupler(282) has been rotatably inserted across the wall as well (i.e., overthe introducer 44) to position an anchor member (136) carried at thedistal end of the helical needle (284) across the ventricular wall (48).An elongate suture member (140) extends proximally from the anchormember (136), around a helical pattern formed in a recess (140, in thedepicted embodiment having a “U” or half-circle cross sectional shapethat runs helically with the needle shape, as depicted) in the helicalneedle (284), and then proximally to a position wherein it may bemanually manipulated either proximal or distal to the chest wall accessport. Referring to FIG. 19B, an operator has started to withdraw theintroducer/dilator assembly (44, 342), leaving the helical needleassembly in place. Referring to FIG. 19C, withdrawal of theintroducer/dilator assembly (44, 342) is continued, and the operatorbegins to helically back out the helical needle (284) with the needlecoupler (282) or other coupled member, while continually letting outslack in the suture member (140) to allow the distal anchor member (136)to remain in place. Referring to FIG. 19D, continued rotational backingout of the helical needle (284), withdrawal of the introducer/dilatorassembly (44, 342), and provision of slack in the suture member (140)enables the compressed viscoelastic tissue to compress (344) the woundshut as the bulk of the instrumentation exits. As described in referenceto FIGS. 18B and 18C, the slack may sequentially be taken out and thesuture member (140) tensioned to form series purse-string tensioningconfigurations within the deployed suture member (140). For example,referring to FIG. 19E, with further withdrawal of the helical needle(284) and introducer/dilator assembly (44, 342), tension may be appliedin the suture member (140) to create a purse string effect in the one ortwo most distal loops of the suture (immediately adjacent the anchormember 136), and with a let-up in tension, slack reforms in the mostproximal helical loops, but the most distal loops retain the pursestring type tension. Referring to FIG. 19F, this may be repeated afterfurther withdrawal of the helical needle (284) and introducer/dilatorassembly (44, 342) to purse-string-close the next set of loopsimmediately proximal to the previously tensioned loops. Furtherrepetition may be utilized to create a very robust closure, as depictedin FIG. 19G, wherein after complete withdrawal of the helical needle(284) and introducer/dilator assembly (44, 342) from the wall (48), asuture buckle assembly (256) may be advanced to retain tension of thedeployed and tightened helical suture member portions, as described, forexample, in reference to FIG. 16E.

Referring to FIGS. 20A-22K, embodiments are depicted wherein anexpandable or inflatable member may be utilized to assist with leakprevention around the outside of a deployed introducer or other similarmember. Such device may further be utilized to assist in closure of theassociated wound or defect, as described in reference to FIGS. 22E-22K.

Referring to FIG. 20A, to prevent fluid leakage at the interface betweena deployed introducer (44) or other similar structure and a leftventricular wall (48) or other similar structure, an inflatable member(376) coupled to a rigid proximal collar member (374), which preferablyis slidably and rotatably coupled around the outer aspect of theintroducer (44), may be advanced (370) over the introducer (44). Theproximal collar member (374) preferably is coupled to a structuralmanipulation member (366) which may comprise an elongate rod or slenderstructure member, and which preferably defines a lumen (368)therethrough which preferably extends through the proximal collar (374)to the inflatable member (376) to facilitate controlled inflation of theinflatable member (376), which may comprise a balloon or similar bladderconstruct configured to have a collapsed configuration (378), such asthat depicted in FIG. 20A, and an expanded configuration (380), such asthat depicted in FIG. 20C. The proximal end of the manipulation membermay be manipulated manually by the operator, or may be coupled toanother member which may be so manipulated, to control insertion,inflation, and roll rotation of the inflatable member (376) and collarmember (374) relative to the introducer (44). Referring to FIG. 20B, theassembly has been further inserted (370) relative to the introducer andtissue structures with the inflatable member (376) in a collapsed state(378) to more easily cross the chest wall (40) access port. Referring toFIG. 20C, the inflatable member (376) has been inflated using theinflation lumen (368) to its expanded state (380), which resembles acompliant frustoconical shape, as illustrated. Referring to FIG. 20D,the expanded (380) inflatable member (376) may be urged against theintersecting introducer (44) and tissue wall (48) region to preventleakage of fluids such as blood past such intersection. Referring toFIG. 20E, the assembly may subsequently be retracted (372), returned toits collapsed expandable member (376) state (378) as in FIG. 20F, andwithdrawn (372) in the collapsed state (378), as depicted in FIG. 20G.

Referring to FIGS. 21A-21J, another embodiment is depicted wherein thewound or defect temporary sealing assistance assembly comprises a distalcollar member (382) coupled to the proximal collar member (374) by theinflatable member (386). As with the inflatable member of FIGS. 20A-20G(376), the inflatable member of FIGS. 21A-21J, and the inflatable memberof FIGS. 22A-22K may comprise an elastomeric medical balloon typematerial, such as polyurethane, configured to be quite expandable andmalleable when in a final expanded shape, or may comprise a relativelyinelastic medical balloon type material, such as polytetrafluoroethyleneor polyethylene terepthalate, configured to assume a final shape and notexpand much beyond such final shape. Referring to the close-up view ofFIG. 21B, the distal collar of the depicted embodiment features a distalsurface with small spike-like contact elements (384) configured toprevent slipping between the distal collar surface and tissues againstwhich it is urged. Referring to FIG. 21C, the assembly is advancedacross the chest wall (40) in a collapsed state (388). Referring to FIG.21D, the expandable member (386) may be expanded with inflation throughthe lumen (368) to the expanded state (390), wherein the expandablemember (386) forms a shoulder-like reinforcing shape around the distalcollar (382) which is suspended and supported by the expandable member(386). Referring to FIG. 21E, the assembly is further inserted to urgethe distal collar member (382) against the tissue surrounding theintersection of the introducer (44) and tissue wall (48) to preventleakage of fluids, such as blood, around the introducer (44). Thecontact elements (384) retain the tissue position relative to theintroducer (44) and distal collar (382) in such configuration. Referringto FIG. 21F, additional insertion loads and/or inflation of theinflatable member (386) may be utilized to create additional sealing ofthe intersection between the introducer (44) and tissue wall (48); suchadditional loading may be pulsed over time to prevent desanguinationand/or lysis of any of the associated tissues (FIG. 21G shows theconfiguration again without the additional loading pulsed on). Referringto FIG. 21H, the assembly may be withdrawn relative to the introducer(44) and tissue wall (48), returned to the collapsed inflatable memberstate (388) as in FIG. 21L, and withdrawn as in FIG. 21J.

Referring to FIGS. 22A-22K, another embodiment is depicted wherein atubular support member (394) is coupled to a tapered distal tip member(396) and circumferential (i.e., like a donut shape around the tubularsupport member; akin to an angioplasty balloon assembly) inflatablemember (392), shown in its compressed state (398) in FIG. 22A. Referringto FIG. 22B, the tubular support member (394) and associated inflatablemember (392) and distal tip member (396) may be advanced past the chestwall (40) with the inflatable member (392) in its collapsedconfiguration. Referring to FIG. 22C, the inflation lumen (368) may beutilized to controllably inflate the inflatable member (392) to itsexpanded state (400). Referring to FIG. 22D, the expanded assembly maybe urged against the defect or wound at the intersection of theintroducer (44) and left ventricular wall (48), with the tapered distaltip member (396) advanced slightly into the wound or defect to assistwith the prevention of leakage of fluids such as blood past theintroducer (44)/tissue wall (48) intersection. In one embodiment, theintroducer may be left in place as in FIGS. 20G and 21J, and a closureconfiguration such as those described above (for example, in referenceto FIGS. 3A-3Z-3, or FIGS. 9A-11B) utilized to ultimately close thedefect or wound left by the introducer. In the embodiment depicted inFIGS. 22E-22K, the defect or wound may be closed utilizing theassistance of the leak prevention assembly described in reference toFIGS. 22A-22D. Referring to FIG. 22E, with the leak prevention assemblyremaining in place as in the configuration of FIG. 22D, retraction (402)of the introducer (44) may be started, with the tissue margins (404,406) collapsing around a void (408) left behind after the introducer iswithdrawn, allowing the compressed viscoelastic tissue to re-expand (80)to its natural position. Referring to FIG. 22F, introducer withdrawal(402) is continued with the leak prevention assembly remaining in placeas in the configuration of FIG. 22D. Similarly, in FIG. 22G, theintroducer withdrawal (402) is continued, and the leak preventionassembly remains in place, while the tissue wall wound margins (404,406) continue to collapse around the void (408) left by the exitingintroducer (44). Referring to FIG. 22H, with adequate time and clotformation, the wound becomes closed (410) and the leak preventionassembly may be withdrawn. Referring to FIG. 22I, the inflatable member(394) may be returned to its collapsed state (398), and the assembly maybe withdrawn (372) past the chest wall (40), as in FIG. 22J. Referringto FIG. 22K, in another embodiment, a similar procedure may beaccomplished with a more substantial proximal construct: in place of thetubular support member (394) and structural manipulation member (366) ofthe embodiments of FIGS. 22A-22J, a single elongate tubular supportmember (412), also defining an inflation lumen (369) therethrough aswell as a working lumen through which an introducer may be slidablydisposed, may be utilized in a similar procedure.

Referring to FIGS. 23-25, various procedural embodiments are depictedwith similarities to those described in reference to FIGS. 20A-22K.Referring to FIG. 23, chest access may be created (168) along withaccess to the left ventricle (170). An introducer sheath may beinstalled (172). An inflatable sealing member may be advanced in ancollapsed configuration across the chest access port along the outsideof the introducer (414). An inflatable sealing member may be expanded toan expanded configuration (416). The expanded configuration may beadvanced toward the junction between the introducer and the leftventricular wall (418). The expanded configuration may be urged againstthe pericardial side of the left ventricular wall (around theintroducer) to prevent leaks around the introducer (420). A diagnosticand/or interventional procedure may be conducted, while leak preventionis continued with the associated assembly, and thediagnostic/interventional hardware may be withdrawn (422). The expandedleak prevention configuration may be partially withdrawn and collapsedback to the collapsed configuration (424). The collapsed configurationmay be withdrawn across the chest wall (426), and a transapical accessclosure may be implemented (428) utilizing the introducer which remainsin place (428). After the closure is completed, the chest access portmay be closed (200).

Referring to FIG. 24, an embodiment similar to that depicted in FIG. 23is shown, but after the step of conducting a diagnostic and/orinterventional procedure and removing the associated instrumentation(422), before withdrawal of the leak prevention assembly, at least thefirst portion of a transapical access closure may be conducted from theinside of the heart first (430), followed by retraction of the expandedleak prevention assembly to accommodate completion of the closure deviceinstallation on the proximal (i.e., pericardial) side (432), retractionof a collapsed configuration of the leak prevention apparatus (434), andclosure of the chest access (200).

Referring to FIG. 25, an embodiment similar to that depicted in FIG. 23is shown, but after the step of conducting a diagnostic and/orinterventional procedure and removing the associated instrumentation(422), the introducer is slowly retracted while leaving the expandedleak prevention assembly in place (436), until the introducer is fullyretracted (438). After sufficient coagulation time, the leak preventionassembly is collapsed and retracted (440), and the chest access closed(200).

Any of the aforementioned deployed structures, including sutures, anchormembers, and ratcheting closure device assembly components, may compriseresorbable materials in addition to the aforementioned nonresorbablematerials—to facilitate combinations and permutations which may becompletely resorbed, leaving behind a biologically healed transapicalaccess wound.

Various exemplary embodiments of the invention are described below.Reference is made to these examples in a non-limiting sense. They areprovided to illustrate more broadly applicable aspects of the invention.Various changes may be made to the invention described and equivalentsmay be substituted without departing from the true spirit and scope ofthe invention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processact(s) or step(s) to the objective(s), spirit or scope of the presentinvention. Further, as will be appreciated by those with skill in theart that each of the individual variations described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinventions. All such modifications are intended to be within the scopeof claims associated with this disclosure.

Any of the devices described for carrying out the subject interventionsmay be provided in packaged combination for use in executing suchinterventions. These supply “kits” further may include instructions foruse and be packaged in sterile trays or containers as commonly employedfor such purposes.

The invention includes methods that may be performed using the subjectdevices. The methods may comprise the act of providing such a suitabledevice. Such provision may be performed by the end user. In other words,the “providing” act merely requires the end user obtain, access,approach, position, set-up, activate, power-up or otherwise act toprovide the requisite device in the subject method. Methods recitedherein may be carried out in any order of the recited events which islogically possible, as well as in the recited order of events.

Exemplary aspects of the invention, together with details regardingmaterial selection and manufacture have been set forth above. As forother details of the present invention, these may be appreciated inconnection with the above-referenced patents and publications as well asgenerally know or appreciated by those with skill in the art. Forexample, one with skill in the art will appreciate that one or morelubricious coatings (e.g., hydrophilic polymers such aspolyvinylpyrrolidone-based compositions, fluoropolymers such astetrafluoroethylene, hydrophilic gel or silicones) may be used inconnection with various portions of the devices, such as relativelylarge interfacial surfaces of movably coupled parts, if desired, forexample, to facilitate low friction manipulation or advancement of suchobjects relative to other portions of the instrumentation or nearbytissue structures. The same may hold true with respect to method-basedaspects of the invention in terms of additional acts as commonly orlogically employed.

In addition, though the invention has been described in reference toseveral examples optionally incorporating various features, theinvention is not to be limited to that which is described or indicatedas contemplated with respect to each variation of the invention. Variouschanges may be made to the invention described and equivalents (whetherrecited herein or not included for the sake of some brevity) may besubstituted without departing from the true spirit and scope of theinvention. In addition, where a range of values is provided, it isunderstood that every intervening value, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention.

Also, it is contemplated that any optional feature of the inventivevariations described may be set forth and claimed independently, or incombination with any one or more of the features described herein.Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin claims associated hereto, the singular forms “a,” “an,” “said,” and“the” include plural referents unless the specifically stated otherwise.In other words, use of the articles allow for “at least one” of thesubject item in the description above as well as claims associated withthis disclosure. It is further noted that such claims may be drafted toexclude any optional element. As such, this statement is intended toserve as antecedent basis for use of such exclusive terminology as“solely,” “only” and the like in connection with the recitation of claimelements, or use of a “negative” limitation.

Without the use of such exclusive terminology, the term “comprising” inclaims associated with this disclosure shall allow for the inclusion ofany additional element—irrespective of whether a given number ofelements are enumerated in such claims, or the addition of a featurecould be regarded as transforming the nature of an element set forth insuch claims. Except as specifically defined herein, all technical andscientific terms used herein are to be given as broad a commonlyunderstood meaning as possible while maintaining claim validity.

1. A system for providing surgical access across a wall of a tissuestructure, comprising: a. a delivery member having proximal and distalends; b. a first helical member having proximal and distal ends and ahelical shape, the proximal end coupled to the delivery member distalend, the distal end extending distally from the delivery member distalend; c. an anchor member removably coupled to the helical member distalend; d. a suture member coupled distally to a portion of the anchormember and extending proximally to a position wherein at least a portionof it may be freely manipulated by an operator; and e. an elongateinstrument at least partially inserted through the first helical member;wherein upon rotation of the delivery member in a first direction, thefirst helical member and coupled anchor member are advanced across atleast a portion of the wall of the tissue structure, pulling along thedistal portion of the suture member in a deployed suture pattern whichremains coupled to the anchor member, the deployed suture pattern beingcharacterized in that it represents a number of helical loopsencapsulated by the wall of the tissue structure that is greater thanabout one and one-half helical loops, and is deployed in a substantiallyhelical configuration selected to movably accommodate the elongateinstrument therethrough.